New Research Shows Unapproved Ingredients in Dietary Supplements Cause Half of Dangerous Drug Recalls
US researchers have found that dietary supplements, which often contain unapproved or unlisted ingredients, make up just over half of all dangerous drug recalls in the United States.
Analysis of FDA data from a 9-year period showed that 51% of Class I recalls – the most serious recalls issued by the FDA – involved adulterated dietary supplements, and not pharmaceutical products. The study was conducted by Ziv Harel, MD, of St. Michael’s Hospital in Toronto, and colleagues, in the Journal of the American Medical Association (JAMA).
Most of the dangerous drug recalls were issued for supplements that claimed to boost sexual performance, build muscle, or aid weight loss. “Supplements” are allowed to contain vitamins, minerals, and herbs, but they are not allowed to contain pharmaceuticals.
The study called for much more stringent guidelines to regulate dietary supplements. Currently, the market has very little FDA oversight. Federal law does not require that supplements – which are supposedly herbal rather than pharmaceutical – go through the FDA for approval before they can be packaged and sold.
However, because of the lack of oversight, supplements containing pharmaceutical compounds have entered the market.
Harel and colleagues used data collected by the FDA about Class I recalls from between January 1, 2004, to December 19, 2012. Of the 465 recalled drugs, 237 were dietary supplements. Nine out of ten of the supplement recalls occurred after 2008. All of the dangerous drug recalls were issued due to unapproved pharmaceutical ingredients.
An additional 110 supplements were known to contain unapproved pharmaceuticals, but were not recalled.
About 24% of the recalled supplements were manufactured outside the US. The study noted this is a concern, as other countries do not adhere to the same manufacturing practices. In the US, supplement manufacturers are expected to adhere to current good manufacturing practices (CGMP) as defined by federal regulations. However, the study also noted that at least half the supplements manufactured in the US violated CGMP.
While no adverse effects were noted in the FDA database, the study focused only on the number of Class I recalls of dangerous drugs and supplements, and was unable to associate the use of many adulterated supplements with adverse side effects. However, the researchers did note that the 1994 Dietary Supplement Health and Education Act (DSHEA) has “permitted the introduction of numerous supplement products, often containing unapproved active pharmaceutical ingredients, into the marketplace, which has led to harm.”
The FDA and Failure to Regulate Dangerous Drug Recalls
Mitchell Katz, MD, said in an editor’s note that the number of dangerous drug recalls “grossly underestimates the number of products on sale with unapproved ingredients.”
“Dietary supplements should be treated with the same rigor as pharmaceutical drugs and with the same goal: to protect consumer health,” Katz wrote.
A 2011 study conducted by Dr. Pieter Cohen, an assistant professor of medicine at Harvard Medical School, found that even supplements that had fallen under Class I dangerous drug recalls could still be purchased. According to Cohen, although the FDA issued the serious recall, it was still voluntary because the FDA has no oversight specifically over supplements. For example, the weight loss supplement Pai You Guo, recalled in 2009 because it contained a banned dangerous drug, could still be bought in 2011.
In March 2013, the FDA issued a notice to consumers that many sexual enhancement drugs contained unreported pharmaceuticals, including Viagra.
Cohen suggested that consumers who want to buy supplements should stick to those with only one ingredient, or just vitamins and minerals. Consumers could also look for supplements that have been certified by the US Pharmacopeial Convention or NSF International, which can provide assurance that the supplements do not contain illegal or unregulated pharmaceuticals.
The Strom Law Firm Can Help with Dangerous Drug Cases
Strom Law Firm, L.L.C. is a leader in the consumer protection battle against dangerous drug recalls and defective devices. We represent individuals who have been killed or injured by dangerous or defective pharmaceuticals. If you or a family member have been injured or killed after using a dangerous drugs or medical products such as Omontys, contact our dangerous drug lawyers as soon as possible so that we can begin taking steps to preserve evidence and your claim immediately. We offer free consultations to discuss the facts of your case. 803.252.4800